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A Site Licence (SL) is required for any Canadian site that manufactures, packages, labels, imports, and/or distributes Natural Health Products (NHPs).
Canadian facilities that only store NHPs do not require a Site Licence but must comply with Good Manufacturing Practices (GMPs) guide for natural health products (GUI-0158). A SL (Site License) is issued by the Health Products and Food Branch to the Regulatory Operations and Enforcement Branch (ROEB) of Health Canada. Site Licensing helps confirm the Canadian market consists of safe, high-quality NHPs. The NNHPD no longer accepts Foreign Site Reference Number applications (SL Bulletin # 10), and NHPs manufactured outside of Canada can no longer maintain their own GMP compliance directly with Health Canada. New NHP brands manufactured outside of Canada need to be partnered with a licensed Canadian importer. The Canadian importer needs to submit the SL application.
SGS Nutrasource can help to support establishing a connection with a licenced Canadian importer to begin this process.
To ensure a smooth NHP SL process, our team will work with you to review your site's Standard Operating Procedures (SOPs) and associated documentation against Good Manufacturing Practices (GMPs) by completing a gap analysis. The goal is to confirm appropriate standards and procedures are implemented for your GMP activities as per the gap analysis. We will prepare and submit all necessary documentation and liaise with the ROEB on your behalf.
